A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis - Tabular View

Tracking Information
First Received Date ^ICMJE	June 4, 2002
Last Updated Date	June 26, 2007
Start Date ^ICMJE	November 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
Official Title ^ICMJE	A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis
Brief Summary	Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Papilloma Recurrent Respiratory Papillomatosis
Intervention ^ICMJE	Drug: SGN-00101
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	27
Completion Date	January 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female between 2 and 18 yrs old, inclusive, who has documented RRP. Patients with documented RRP Subject is surgically debulked within 7 days before the first dose of SGN-00101. Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries. Subject is free of life threatening or serious concomitant disorders other than the disease under study. Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator. Exclusion Criteria: Subject has disease or status that causes compromise of the immune system. Subject has a history of ionizing radiation therapy to the respiratory tract. Patient has used concomitant medications that may suppress the immune system. Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study. Subject has participated in a past study with SGN-00101 Pregnancy and lactation.
Gender	Both
Ages	2 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038714
Responsible Party
Study ID Numbers ^ICMJE	Stressgen SGN-00101-0005, SGN-00101-0005
Study Sponsor ^ICMJE	Nventa Biopharmaceuticals Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Nventa Biopharmaceuticals Corporation
Verification Date	June 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP